FDA clears Arctic Sun 5000 patient cooling device for therapeutic hypothermia, normothermia

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Medivance today announced the introduction of its next-generation therapeutic temperature management device, the non-invasive Arctic Sun® 5000.  The new patient cooling device has received FDA 510 (k) clearance and offers the fastest initiation of treatment, simplest programming capabilities and easiest access to treatment data on the market.

"We beta tested the new device for six months and it's an incredible machine for both therapeutic hypothermia and normothermia indications," said Mary Kay Bader, RN, MSN, CCNS, FAHA of California's Mission Hospital, a nationally renowned cooling expert.  "It's so easy to use and has new functions we find very valuable."

Ms. Bader and others cite the Arctic Sun's pre-programmed protocols and new trend analysis and data collection capabilities as key enhancements that optimize patient care.

"The entire staff loved the Arctic Sun 5000," Bader said.

Favored by hospitals worldwide for its safety, simplicity and precision, the newest Arctic Sun also features:

  • Embedded training
  • The ability to pre-program hospital protocols for rapid induction of temperature control with the push of a button
  • Comprehensive help screen with pop-up explanations for all alerts
  • Voice and visual prompts for added safety
  • Data storage during patient transfers, with ability to "continue current patient case" for up to 6 hours
  • More efficient cooling
  • Touch screen
  • Ability to download up to 10 cases from device memory for research or analysis purposes
  • Automatic initiation of rewarming

"The Arctic Sun 5000 brings precision Targeted Temperature Management™ to the highest level of performance available today," said Medivance CEO Robert Kline.  "With the Arctic Sun 5000 we have made it as effortless as possible to initiate this promising non-invasive therapy that may spare many more critically ill patients from devastating brain damage."

Source:

Medivance

Comments

  1. PQ PQ United States says:

    Interesting that they claim they are cleared for Therapeutic Hypothermia when the 510(k) does not indicate that!!!  Maybe the FDA can weigh in on the claim made versus the published record.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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